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Intra-Operative TEC Atherectomy System

by Intensive Technology, Inc.

510(k) K922970

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK922970 Date13 Jan 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MCW
Device Class
Class II
Regulation
21 CFR Part 870.4875
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Intra-Operative TEC Atherectomy System is a catheter-based peripheral atherectomy device classified under product code MCW and regulation number 870.4875. It is designed for the removal of plaque from peripheral blood vessels during surgical procedures.

The system was cleared via the FDA 510(k) pathway under K922970 on January 13, 1993, and is manufactured by Intensive Technology, Inc. It is a Class 2 medical device intended for use in cardiovascular interventions.

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Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Intra-Operative TEC Atherectomy System used for?

    The Intra-Operative TEC Atherectomy System is designed for the removal of plaque from peripheral blood vessels during surgical procedures. It is a catheter-based peripheral atherectomy device intended for use in cardiovascular interventions to treat atherosclerotic lesions in arteries outside the heart and brain.

  • How is the Intra-Operative TEC Atherectomy System supplied and is it reusable?

    The device data does not specify whether the system is supplied sterile or non-sterile, or whether it is intended for single-use or reuse. As a catheter-based atherectomy system, it is typically designed for single-use in clinical settings, but this detail is not explicitly stated in the provided information. Users should consult the manufacturer's labeling for specific instructions on supply condition and reuse.

  • What regulatory pathway was used to clear the Intra-Operative TEC Atherectomy System?

    The Intra-Operative TEC Atherectomy System was cleared via the FDA 510(k) pathway under submission number K922970, with a decision date of January 13, 1993. It was found substantially equivalent to a predicate device and is classified as a Class 2 medical device under product code MCW and regulation number 870.4875.